The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:

Opening/closing base wedge osteotomies,
Distal and proximal chevron osteotomies,
Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
Primary MTP fusion due to hallux rigidus and/or hallux valgus,
Revision MTP fusion,
Revision of failed first MTP arthroplasty implant,
Metatarsal and Phalanges:
Metatarsal and phalanges fractures and osteotomies;
Mid / Hindfoot Fusions:
Tarsometatarsal (TMT) fusions/stabilization,
Intercuneiform fusions.

Device Description

The TriMed ASET™ Foot Plating System is a multi-indication total foot plating system which provides surgical options for fractures, osteotomes and arthrodesis of the forefoot, midfoot and hindfoot. Plates and screws are made from implant grade titanium alloy. Implant offerings are as followed: 15 MTP fusion plates, Lapidus (With and without hooks) plates, Universal Straight plates, Universal Hook plates, and Universal T-Plates. 2.7mm, 3.5mm, and 4.0mm variable angle and nonlocking screws are also included.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "TriMed ASET™ Foot Plating System." This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity in an AI/imaging context.

The document discusses mechanical and biological acceptance criteria for the physical device (plates and screws), not performance criteria related to a diagnostic or AI-driven medical device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.

Here's how the available information relates to your request:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Plates (Static Bending)	Subject plates were stronger than the predicate.
Plates (Fatigue Bending)	Subject plates were equivalent to the predicate.
Screws (Torsional Strength)	Subject screws were stronger than the predicate.
Screws (Axial Pullout Testing)	Subject screws were stronger than the predicate.
Screws (Insertion/Removal Torque)	Insertion torque was equivalent to the predicate and appropriate compared to torsional strength.
Biological/Structural	Similar technological characteristics, indications for use, and performance testing support substantial equivalence. Designs do not adversely affect product performance, cleanability, and sterilization.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes mechanical testing of physical implants, not a clinical study involving human data or a test set in the context of an AI/imaging device. The "test set" would refer to the physical samples of the plates and screws used in the mechanical tests. The document does not specify the number of physical samples tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in this context refers to the measured mechanical properties. These are established through standardized engineering tests, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This pertains to consensus among experts in interpreting clinical data, which is not relevant for mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a mechanical device, not an AI or imaging device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is based on engineering standards and mechanical testing results (e.g., measured strength, fatigue life, torque, pullout force) as compared to the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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January 5, 2020

Image /page/0/Picture/11 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

TirMed, Inc. David Anderson Principle Consultant Tech2Med, LLC 6450 Old Darby TRL NE Ada, MI 49301

Re: K192696

Trade/Device Name: TriMed ASET Foot Plating system Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: October 10, 2019 Received: October 11, 2019

Dear David Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192696

Device Name The TriMed ASET Foot System

Indications for Use (Describe)

Specific examples include:

First metatarsal osteotomies for hallux valgus and hallux varus correction including:

· Opening/closing base wedge osteotomies,
· Distal and proximal chevron osteotomies,

Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

· Primary MTP fusion due to hallux rigidus and/or hallux valgus,
· Revision MTP fusion,
· Revision of failed first MTP arthroplasty implant,

Metatarsal and Phalanges:

· Metatarsal and phalanges fractures and osteotomies;

Mid / Hindfoot Fusions:

· Tarsometatarsal (TMT) fusions/stabilization,
Intercuneiform fusions.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the TriMed logo in blue. Below the logo is the text "K192696 Page 1 / 2". The logo consists of a stylized symbol and the word "TriMed".

510(K) SUMMARY

(a)(1). Submitted By:	TriMed, Inc.27533 Avenue HopkinsSanta Clarita, CA 91355United States of America
Contact Person:	David AndersonPrinciple Regulatory ConsultantOffice - (574) 377-0111Fax – (661) 254-8485
Date:	January 2, 2020
(a)(2). Proprietary Name:	TriMed ASET™ Foot Plating System
Common Name(s):	Plate, Fixation, Bone
Classification Name:	21 CFR 888.3030: Single/multiple component metallicbone fixation appliances and accessories
Regulatory Class:Product Codes:	IIHRS, HWC
(a)(3). Predicate Device:	K072740: Mondeal Extremity Bone Fixation System, MondealNorth America, Inc. (Primary)K152974: The ORTHOLOC® 3Di Foot Reconstruction System,Wright Medical Technology, Inc.

(a)(4). Device Description

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Image /page/4/Picture/0 description: The image shows the TriMed logo in blue. Below the logo is the text "K192696 Page 2 / 2". The logo consists of a stylized symbol and the word "TriMed" in a sans-serif font.

(a)(5). Indications for Use

The TriMed ASET™ Foot Plating System is intended for use in stabilization of fractures, revision procedures, joint fusion, reconstruction, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:

First metatarsal osteotomies for hallux valgus and hallux varus correction including:

· Opening/closing base wedge osteotomies,
· Distal and proximal chevron osteotomies,

Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion);

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

Primary MTP fusion due to hallux rigidus and/or hallux valgus,
· Revision MTP fusion,
· Revision of failed first MTP arthroplasty implant,
Metatarsal and Phalanges:
Metatarsal and phalanges fractures and osteotomies;
Mid / Hindfoot Fusions:
· Tarsometatarsal (TMT) fusions/stabilization,
· Intercuneiform fusions.

(a)(6). Technological Characterizes

The subject devices included in The TriMed ASET™ Foot Plating System are similar to predicate devices in material, size, and bending strength. The subject plates differ slightly in geometry and may contain hook features.

(b)(1). Substantial Equivalence: - Non-Clinical Evidence

The plates were evaluated against the predicate in static and fatigue three-point bend testing. The subject plates were stronger in static bending and equivalent in fatigue bending. The screws were evaluated in ASTM F543 torsional strength testing, insertion/removal torque testing and axial pullout testing. The subject screws were stronger in torsion testing and pullout testing. The insertion torque was equivalent to the predicate and was appropriate compared to the torsional strength.

(b)(2). Substantial Equivalence: - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

TriMed ASET™ Foot Plating System plate, screw, surgical instrument, and tray designs do not adversely affect product performance, cleanability, and sterilization and therefore do not raise any new concerns of safety and efficacy. The similar technological characteristics, indications for use and performance testing support the substantial equivalence of the TriMed ASET™ Foot Plating System with the predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.